Discussion on Pharmaceutical Research of Additional Specifications of Traditional Chinese Medicine Honey Pills Based on Characteristics of Traditional Chinese Medicine
10.13422/j.cnki.syfjx.20220948
- VernacularTitle:基于中药特点探讨中药蜜丸增加规格的药学研究
- Author:
Tianjiao ZHENG
1
;
Wei HAN
1
Author Information
1. Center for Drug Evaluation，National Medical Products Administration，Beijing 100022，China
- Publication Type:Journal Article
- Keywords:
Chinese medicine;
honey pills;
specifications;
change of process;
safety;
water pills
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2023;29(1):209-214
- CountryChina
- Language:Chinese
-
Abstract:
Among the supplementary applications for Chinese medicines， additional specifications of pills occupy a certain proportion. It is common situation that addition of water honey pills and water pills on the basis of honey pills. Due to the ingredients of Chinese medicine are complex， and honey may be related to the safety and effectiveness of the preparation as a special excipient. Therefore， the necessity of the change should be considered from multiple perspectives and aspects in combination with the characteristics of the pills， and the scientific and reasonable nature of the change should be proved through research. By thinking deeply of the review of the application for adding water honey pill and water pill specification supplement to honey pill， the author discusses the key contents that need to be paid attention to in pharmaceutical research of such changes， and puts forward the following suggestions：①The necessity of change should be considered in combination with clinical drug demand and benefit-risk ratio. ②Attach importance to the research on the change of process and excipient， and evaluate the impact of changes on drug safety and effectiveness. ③Strengthen quality and stability research， and select appropriate packaging materials to ensure stable and controllable sample quality after change. ④Reasonably expression of specifications and loading specifications.
